A Gift for Drug Makers

By BOB HERBERT

New York Times

January 14, 2005

Vioxx, Celebrex, Prozac. ...

With all the problems and the bad publicity that drug companies have been facing recently, you might think that this would not be a good time for the Bush administration to toss yet another bonanza their way.

But the administration is like an ardent lover in its zeal to shower the rich and powerful with every imaginable benefit. So tucked like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful.

The provision would go beyond caps on certain damages. It would actually prohibit punitive damages in cases in which the drug or medical device had received Food and Drug Administration approval. We know the F.D.A. has failed time and again to ensure that unsafe drugs are kept off the market. To provide blanket legal protection against punitive damages in such cases is both unwarranted and dangerous.

We learned just last month that Celebrex, the phenomenally popular painkiller from Pfizer, more than tripled the risk of heart attacks, strokes and death among those taking high doses in a national trial. Those findings, as noted in an article in The Times, "raised new questions about how well federal drug regulators protect the public and worsened drug makers' already dismal image."

Senator Chuck Grassley, an Iowa Republican who held hearings on recent F.D.A. actions, said, "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us."

The Celebrex disclosure came on the heels of a decision by Merck to withdraw its arthritis drug Vioxx from the market after a study showed a link between long-term use of the drug and an increased risk of heart attacks and strokes.

Two weeks ago, an article in The British Medical Journal suggested that Eli Lilly & Company had long concealed evidence that the antidepressant Prozac could cause violent and suicidal behavior. The company denies the accusation, which the journal forwarded to the F.D.A.

If the malpractice legislation so relentlessly touted by President Bush became law, Pfizer, Merck and Eli Lilly would be immunized against even the possibility of punitive damages arising from any harm to patients that resulted from use of these drugs - as long as the companies followed F.D.A. rules. All three drugs were approved by the F.D.A.

The whole idea behind punitive damages is to severely punish the most egregious offenders. Huge punitive damage awards are supposed to serve as a deterrent to extremely bad behavior.

"It's an important system to have in place," said Joanne Doroshow, executive director of the Center for Justice and Democracy, a nonprofit consumer advocacy group. "The F.D.A. is certainly not doing its job. The legal system is a very important backup. It's really the last line of defense to ensure that the marketplace only has safe products."

If Mr. Bush has his way, that line of defense will be substantially weakened. With the possibility of punitive damages eliminated, drug companies will be even less vigilant than they are now about problems with products that pose a serious - even fatal - threat to patients.

The Democratic leader in the Senate, Harry Reid of Nevada, was blunt on the matter. He said, "Congress should not be giving a free pass to big drug companies at a time when millions of Americans may have had their health put at risk by pharmaceutical giants."

The drug companies have an incredible racket going, as Marcia Angell, the former editor in chief of The New England Journal of Medicine, documents in her book "The Truth About the Drug Companies."

"Now primarily a marketing machine to sell drugs of dubious benefit," she wrote, "this industry uses its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)"

Among those co-opted is the president himself. Nothing's too good for the drug companies. If ordinary Americans got the same sweet treatment from this administration as the great pharmaceutical houses, we'd all be in a much better place.